DyslipidemiasPhase 1NCT07634510
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWX205
A Phase 1 study testing MWX205 in people with Dyslipidemias, run by Shanghai Minwei Biotechnology Co., Ltd.
Trial summary
This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia). Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- MWX205
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 22 Jun 2026to 8 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult participants with dyslipidemia will be enrolled in this study.
- The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- Participants must have fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) and less than 500 mg/dL (5.7 mmol/L), and LDL-C greater than or equal to 70 mg/dL (1.8 mmol/L) at pre-screening and confirmation within 7 days before randomization.
- Have a body mass index within the range 18.5 to 40.0 kg/m2 (inclusive), with no plans to significantly alter diet or BMI over the course of study.
- Females of childbearing potential and males who are not surgically sterile (> 90 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 6 months after the administration, OR females of non-reproductive potential
Who cannot join
- Positive pregnancy test or lactating female participant.
- Systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm at screening.
- QTcF over 450 ms at screening.
- Consume more than 7 units for women or 14 units for men of alcohol per week within 8 weeks prior to screening (1 unit = 285 mL of beer 3.5%, 75 mL of wine 13.5%, or 25 mL of distilled alcohol 40%).
- Participants with established coronary artery disease, peripheral arterial disease, prior stroke, or other clinically significant atherosclerotic cardiovascular disease (such as stent placement or heart bypass, unstable angina or last known ejection fraction of <50%).
- History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc.), or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction.
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- Have taken any prescription medications that are specifically indicated for lowering serum TGs (e.g., fibric acid derivatives, niacin, and omega-3 fatty acids [>1 g/day]) or medications that interfere with absorption of dietary cholesterol or fats (e.g., bile acid sequestrants, orlistat) within 2 months prior to screening.
- Have received treatment with any liver-targeted siRNA therapy or ASO (Antisense Oligonucleotide) within12 months prior to screening.
- Use of ANGPTL3 or PCSK9-inhibiting monoclonal antibodies within 90 days prior to screening.
- Use of systemic glucocorticoid therapy for more than 14 consecutive days in the past year, or any glucocorticoid therapy (excluding topical, intra-ocular, intra-articular, intranasal, or inhaled preparations) within 1 month before screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MWX205 Injection in Adult Participants With Dyslipidemia
This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia).
Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. They will also measure how quickly the drug enters the bloodstream and how long it stays in the body, and compare it with a placebo (inactive treatment).
The study will help decide the right dose and understand how this medicine could be used in future treatments.
The main questions this study aims to answer are:
- Is MWX205 safe after a single dose?
- How does the body process MWX205?
- Does MWX205 show any effect on the body related to cholesterol levels?
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MWX205 Injection will be assessed in adult participants with dyslipidemia.
Overall, 37 participants will be enrolled and assigned to 5 sequential cohorts (Cohorts 1 through 5).
Cohort 1 will enroll 5 participants and be randomized 3:2 to receive a single dose of MWX205 or placebo (3 participants receiving MWX205 and 2 receiving a placebo).
Cohorts 2 to 5 will be comprised of 8 participants per Cohort and randomized 3:1 to receive a single dose of MWX205 or placebo, respectively (6 participants receiving MWX205 Injection and 2 receiving a placebo).
Dosing in each cohort will be such that 2 participants (1 MWX205 Injection and 1 placebo) will be administered at least 24 hours before the remaining 3 participants (the first cohort) or 6 participants (cohorts 2-5). After dosing the first 2 participants on a separate day, a minimum of a 5-minute dosing interval for the remaining 3 participants (the first cohort), or 6 participants (cohorts 2-5) in the following cohort, is considered acceptable.
Continuation to dose the remaining 3 participants (Cohort 1) or 6 participants (Cohorts 2-5) will be at the investigator's discretion.
Each participant will participate in 1 cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 8.
- Conditions
- Dyslipidemias
- Being tested
- MWX205, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWX205Drug
Each vial contains 200mg of MWX205 small nucleic acid, with water for injection as the solvent. The excipient, including sodium hydroxide and/or hydrochloric acid, may be added to adjust the pH to 6.5±0.2.
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| MWX205 | Experimental | Strength: 1ml: 200 mg Proposed dose levels for SAD study: 50, 200, 400, 800, and 1200 mg Administration: subcutaneous injection, recommended in the abdomen. Receives: Drug: MWX205 |
| Placebo | Placebo comparator | Administration: subcutaneous injection, recommended in the abdomen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of TEAEs
Measured: From Day 1 to Day 86
Incidence of SAEs
Measured: From Day 1 to Day 86
Number of participants with abnormal vital signs
Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate
Measured: From Day 1 to Day 86
Number of participants with abnormal Physical examination findings
Complete physical examinations include general appearance, mouth/dental (if required), neck (including thyroid \& nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, other
Measured: From Day 1 to Day 337
Number of participants with abnormal ECG readings
12 Lead ECG: Triplicate readings to be taken within 2 to 5 minutes of each other. ECGs are to be taken after the participant has rested in the supine position for ≥ 5 minutes
Measured: From Day 1 to Day 337
Secondary outcomes (6)
Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Urine PK parameters- Fe (dose fraction of the drug in its original form excreted in urine after administration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Urine PK parameters- Ae (cumulative excretion of the drug's original form in urine)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Measured: Day 1, Day 2, Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion26 Oct 2026 (estimated)
- Study completion8 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohd Naguib bin Mohd Yunos, Dr., Principal investigator, Veritus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634510
- Sponsor's protocol ID
- MWX205-101
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MWX205 Injection in Adult Participants With Dyslipidemia
- ClinicalTrials.gov ID
- NCT07634510
- Acronym / sponsor ID
- MWX205-101
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 8 Nov 2027 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia).
Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. They will also measure how quickly the drug enters the bloodstream and how long it stays in the body, and compare it with a placebo (inactive treatment).
The study will help decide the right dose and understand how this medicine could be used in future treatments.
The main questions this study aims to answer are:
- Is MWX205 safe after a single dose?
- How does the body process MWX205?
- Does MWX205 show any effect on the body related to cholesterol levels?
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MWX205 Injection will be assessed in adult participants with dyslipidemia.
Overall, 37 participants will be enrolled and assigned to 5 sequential cohorts (Cohorts 1 through 5).
Cohort 1 will enroll 5 participants and be randomized 3:2 to receive a single dose of MWX205 or placebo (3 participants receiving MWX205 and 2 receiving a placebo).
Cohorts 2 to 5 will be comprised of 8 participants per Cohort and randomized 3:1 to receive a single dose of MWX205 or placebo, respectively (6 participants receiving MWX205 Injection and 2 receiving a placebo).
Dosing in each cohort will be such that 2 participants (1 MWX205 Injection and 1 placebo) will be administered at least 24 hours before the remaining 3 participants (the first cohort) or 6 participants (cohorts 2-5). After dosing the first 2 participants on a separate day, a minimum of a 5-minute dosing interval for the remaining 3 participants (the first cohort), or 6 participants (cohorts 2-5) in the following cohort, is considered acceptable.
Continuation to dose the remaining 3 participants (Cohort 1) or 6 participants (Cohorts 2-5) will be at the investigator's discretion.
Each participant will participate in 1 cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MWX205 | Experimental | Drug: MWX205Strength: 1ml: 200 mg Proposed dose levels for SAD study: 50, 200, 400, 800, and 1200 mg Administration: subcutaneous injection, recommended in the abdomen. |
| Placebo | Placebo comparator | Drug: PlaceboAdministration: subcutaneous injection, recommended in the abdomen. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult participants with dyslipidemia will be enrolled in this study.
- The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
- Participants must have fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) and less than 500 mg/dL (5.7 mmol/L), and LDL-C greater than or equal to 70 mg/dL (1.8 mmol/L) at pre-screening and confirmation within 7 days before randomization.
- Have a body mass index within the range 18.5 to 40.0 kg/m2 (inclusive), with no plans to significantly alter diet or BMI over the course of study.
- Females of childbearing potential and males who are not surgically sterile (> 90 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 6 months after the administration, OR females of non-reproductive potential
Key exclusion criteria (10 listed)
- Positive pregnancy test or lactating female participant.
- Systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm at screening.
- QTcF over 450 ms at screening.
- Consume more than 7 units for women or 14 units for men of alcohol per week within 8 weeks prior to screening (1 unit = 285 mL of beer 3.5%, 75 mL of wine 13.5%, or 25 mL of distilled alcohol 40%).
- Participants with established coronary artery disease, peripheral arterial disease, prior stroke, or other clinically significant atherosclerotic cardiovascular disease (such as stent placement or heart bypass, unstable angina or last known ejection fraction of <50%).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MWX205Each vial contains 200mg of MWX205 small nucleic acid, with water for injection as the solvent. The excipient, including sodium hydroxide and/or hydrochloric acid, may be added to adjust the pH to 6.5±0.2. | Drug | MWX205 |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Incidence of TEAEs
Time frame: From Day 1 to Day 86
Incidence of SAEs
Time frame: From Day 1 to Day 86
Number of participants with abnormal vital signs
Time frame: From Day 1 to Day 86
Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate
Number of participants with abnormal Physical examination findings
Time frame: From Day 1 to Day 337
Complete physical examinations include general appearance, mouth/dental (if required), neck (including thyroid \& nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, other
Number of participants with abnormal ECG readings
Time frame: From Day 1 to Day 337
12 Lead ECG: Triplicate readings to be taken within 2 to 5 minutes of each other. ECGs are to be taken after the participant has rested in the supine position for ≥ 5 minutes
6 secondary outcomes
Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)
Time frame: Day 1, Day 2, Day 3
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Time frame: Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Time frame: Day 1, Day 2, Day 3
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Time frame: Day 1, Day 2, Day 3
Urine PK parameters- Fe (dose fraction of the drug in its original form excreted in urine after administration)
Time frame: Day 1, Day 2, Day 3
Urine PK parameters- Ae (cumulative excretion of the drug's original form in urine)
Time frame: Day 1, Day 2, Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohd Naguib bin Mohd Yunos, Dr. principal investigator
Veritus Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MWX205 in people with Dyslipidemias, run by Shanghai Minwei Biotechnology Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohd Naguib bin Mohd Yunos, Dr. (+61 0387361750, naguibyunos@veritusresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAEs (time frame: From Day 1 to Day 86). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.